Pathogen dematerialization and the ABS loophole

Law School, Oxford University Press, and Stanford Law School. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. Journal of Law and the Biosciences, 1–20 https://doi.org/10.1093/jlb/lsad002 Essay


I. INTRODUCTION
As COVID-19 has most recently highlighted, the timely sharing of pathogen samples (both their physical form and associated information) plays a crucial role in preparing for and responding to health emergencies. 2 The level of importance attributed to pathogen sharing is a direct result of access to novel pathogen samples not only facilitating the completion of risk assessments but also permitting the adaptation of anti-viral medication and the development of vaccine and diagnostic kits, 3 all of which are vital for the protection of global public health. 4 Serving as a somewhat reflection gain sufficient and timely access to such resources due to developed states dominating procurement. 11 Developing states have long faced considerable struggles to procure sufficient access to medical countermeasures during health emergencies. 12 The experiences of the Global South during the COVID-19 pandemic have most recently highlighted the overwhelming disparities which exist between developed and developing states during a health emergency; 13 with this presenting a problem for global public health and global health justice. The favored solution to these problems has been the replacement of the informal system of pathogen sharing with one which uses transactional Access and Benefit Sharing (ABS) agreements; with developing states now being encouraged to use their sovereign genetic resources, 14 in this case pathogen samples, as 'bargaining chips' which can be traded in exchange for access to medical countermeasures during a health emergency. 15 With the intention of placing the equitable sharing of benefits on equal footing with the sharing of pathogen samples, the use of ABS within global public health seeks to ensure the provision of equity, fairness and justice in relation to the ability of developing states to access medical countermeasures during a health emergency, whilst also ensuring the timely sharing of pathogen samples on a global scale.
The ability of ABS agreements within global public health to achieve equity and fairness in the distribution of benefits has become increasingly threatened in recent years by rising levels of pathogen dematerialization; with pathogen dematerialization referring to the act(s) of separating information from physical pathogen samples, thereby reducing the need to access physical samples. This paper presents the argument that the ability of dematerialized pathogen samples to circumvent the benefit-sharing obligations of ABS mechanisms and the subsequent production of a 'benefit-sharing loophole' produces a number of concerns surrounding not only the functionality of ABS agreements, but also their ability to ensure fairness, equity, and global health justice. Whilst this paper initially seeks to provide a solution to the problem through identifying the avenues through which DSI could become included within the ABS transaction, it ultimately concludes that the use of ABS within global public health 11 Eccleston-Turner and Rourke, supra note 4, at 829. . 14 This paper utilises several phrases, such as biological materials, physical samples, physical pathogen samples and physical genetic resources, which should all be understood to refer back to 'genetic resources.' Differences in the language utilised here are a result of the need to draw a distinction between 'genetic resources' as a whole and (physical) pathogen samples for the purpose of this paper and wider discussion. Equally, variations in the terminology used here, particularly with regards to direct quotations which this paper utilises, serve to reflect the inconsistencies in language which are present throughout the literature and policy documents, highlighting the level of uncertainty which exists not only around DSI but around genetic resources under the ABS regime as a whole. 15 Eccleston-Turner and Rourke, supra note 4, at 828. should be abandoned and that an alternative solution(s) must be found in order to deliver global health justice. As such, this paper will first explore the extent to which the dematerialization of pathogen samples represents a threat to global health justice, considering the use of ABS within global public health alongside the failure of international ABS agreements to include dematerialized virus samples within their scope and the impact had on the distribution of benefits as a result. Following the initial framing of the problem, this paper will conclude with an examination of the potential solutions to the myriad of problems posed by synthetic biology 16 in the context of ABS agreements and the distribution of medical countermeasures before ultimately proposing an alternative solution.

II. ABS IN GLOBAL PUBLIC HEALTH
Following the recognition that pathogen samples amount to sovereign genetic resources, as opposed to 'common pool resources', 17 the use of ABS has expanded beyond its original role in biodiversity conservation 18 to become the favored policy approach to pathogen sharing within global public health. In doing so, it has sought to provide a single 'market-based solution' to the two distinct public health problems outlined above: the need for third party users to gain timely access to pathogen samples and the difficulties faced by developing states with regards to accessing medical countermeasures during a health emergency. 19 Taking the form of a transaction between the 'user' and 'provider' of genetic resources, the ABS agreement regulates the way in which genetic resources can be accessed and how the benefits resulting from their utilization should then be shared with the 'provider'. 20 A trade occurs between the two parties, with access to genetic resources being contingent upon access to benefits and vice versa. In the context of pathogen sharing, developing states trade or provide access to the physical pathogen samples collected within their borders in exchange for access to vaccine and other medical countermeasures during a health emergency. These ABS obligations are provided by the Convention on Biological Diversity 21 (CBD or the Convention); its supplementary agreement, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity 22 (Nagoya Protocol); and the Pandemic Influenza Preparedness Framework 23 (PIP Framework). 24

II.A. The CBD & the Nagoya Protocol
The ABS obligations provided for by the CBD and the Nagoya Protocol find their basis in the mutual aim of both agreements to ensure 'the fair and equitable sharing of the benefits arising out of the utilization of genetic resources'. 25 Both the CBD and the Nagoya Protocol favor a bilateral approach to the ABS transaction, with such agreements being negotiated between two parties-the 'user' and the 'provider' of genetic resources. Building upon the ABS obligations first specified by the CBD, 26 the Nagoya Protocol places an obligation on 'users' of genetic resources to first obtain Prior Informed Consent (PIC), 27 with this taking the form of a permit which allows the 'user' to collect genetic resources from a specified area. 28 In addition to PIC, Mutually Agreed Terms (MAT) must also be negotiated, 29 with these terms specifying not only the way in which those resources may then be utilized, but also the benefit-sharing obligations which the 'user' is required to agree to before access to genetic resources can be granted. 30 Whilst the use of MAT by the CBD and the Nagoya Protocol offers a level of assurance to 'providers' of genetic resources that benefits will be shared, with it being the use of MAT here which makes the ABS agreement a legally binding contract, issues surrounding compliance with national ABS legislation and the ABS negotiation process, specifically the length of negotiations, 31 cast doubt on the suitability of bilateral ABS agreements to pathogen sharing-where access to samples is time sensitiveand on their ability to procure sufficient benefits for developing states during a health emergency.

II.B. The PIP Framework
The PIP Framework seeks to create 'a fair, transparent, equitable, efficient, effective system for, on an equal footing: (i) the sharing of H5N1 and other influenza viruses with human pandemic potential and (ii) access to vaccines and sharing of other benefits'. 32 Restricted in scope to the sharing of influenza viruses with human pandemic potential and the benefits resulting from their use, 33 the Framework takes a multilateral approach to the ABS transaction, with the World Health Organization (WHO) taking on the role of 'mediator' as opposed to negotiations simply taking place between the 'user' and 'provider' of samples. 34 The role of the WHO here as 'mediator' was expected to result in a more just and fair outcome for developing states. 35 Doubt has been cast as to whether these expectations have and are capable of truly being met, however, with the bargaining power of the WHO as an intermediary actor here lacking the strength and conviction which was anticipated during the negotiation of the PIP Framework.
The Framework provides for recommendations in two areas: the timely sharing of influenza samples with human pandemic potential between member states and the WHO via GISRS; 36 and the sharing of virus samples with third-party entities that operate outside of the GISRS network, such as vaccine manufacturers, in return for these external entities sharing benefits with the WHO for distribution to member states. 37 The PIP Framework introduced ABS through the use of legally binding Standard Material Transfer Agreements (SMTAs), 38 with their standard frameworks changing in accordance with whether the sample is being shared with a GISRS or non-GISRS entity. 39 Whilst SMTA1s refer to the transfer of samples within the GISRS Network, SMTA2s place benefit-sharing obligations on those Non-GISRS entities which receive access to influenza viruses samples with human pandemic potential. 40  non-GISRS entity to receive access to virus samples, they must enter into a SMTA2 and commit to a minimum of two of the benefits specified by Annex 2 of the PIP Framework. 41 Although the use of SMTA2s by the PIP Framework was expected to ensure the fair and equitable distribution of pandemic influenza vaccine and other medical countermeasures during an influenza pandemic, 42 the WHO has consistently being unable to secure sufficient benefit-sharing commitments from vaccine manufacturers and other members of the pharmaceutical industry. 43 With the PIP Framework yet to be put to the test during an influenza pandemic, it appears unlikely that it will work as expected with regards to its ability to deliver sufficient benefits-alongside equity, fairness, and justice-to developing states.

II.C. ABS: A Great Success?
Whilst the form which ABS takes may differ across the CBD, the Nagoya Protocol and the PIP Framework, the approach remains transactional in nature. 44 Although taking such an approach comes with an array of problems, largely due to the conflicting interests of each party to the transaction, 45 the use of ABS as a whole has been praised as a means of delivering justice, equity and fairness to developing states. 46 Much of this praise has translated to its use in global health amidst claims that the PIP Framework's use of ABS was its 'greatest accomplishment for equity'. 47 Such praise is to be somewhat expected given the rationale behind the use of ABS more broadly and its supposed role in reducing colonial inequalities and rectifying the power imbalances which have long existed between developed and developing states as a result of biopiracy 48 and bio-colonialism. 49 Emerging from the demands of the Global South, support for the 41 PIP Framework, supra note 23, Annex 2. These benefits include, but are not limited to, the donation of vaccine and the donation of antiviral medication. 42 Jefferies, supra note 38, at 66. use of ABS, within global public health and more broadly, flows not only from its perceived ability to place benefit-sharing on equal footing with pathogen sharing, but also the expectation that it is able to place developing states on equal footing with their developed counterparts. 50 It is important to note at this stage, however, that much of the praise surrounding the use of ABS in global health as a means of delivering justice, equity, and fairness to developing states-whether that be specific to the context of pandemic influenza and the PIP Framework or with regards to the sharing of pathogens as a whole-is rhetorical, and premised on how it is expected to work as opposed to the actual, tangible benefits which have been delivered to developing states as a result, with expectation and reality often being misaligned here. Despite this, ABS agreements are commonly viewed, whether rightly or wrongly, to be vital for developing states which have struggled to access vaccine and other medical countermeasures during a health emergency. With the continued existence of barriers to self-procurement, such as financing and manufacturing capacity, 51 the successful negotiation of an ABS agreement is widely considered to be the only means of ensuring equitable access to benefits for developing states. 52 The ability of ABS agreements to ensure equity and justice in the context of benefit-sharing, however, is increasingly under threat as a result of developments in synthetic biology and rapid levels of pathogen dematerialization.

III. PATHOGEN DEMATERIALIZATION: A THREAT TO ABS AND GLOBAL HEALTH JUSTICE
The rapid levels of growth and development within the field of synthetic biology in recent years have undoubtedly produced an array of benefits, 53 and potentially catastrophic risks. Until fairly recently, it was impossible to detach physical pathogen samples from the information they contained-the sample was the informationbut technological advancements have allowed for the dematerialization of pathogen  56 repositories having existed since the 1990s, recent technological innovations are beginning to enable the use of this information in many areas of pandemic preparedness and response; going as far as to form a substitution for 'physical pathogen samples during pandemic risk assessment and the development of commercial products'. 57 Whilst physical pathogen samples continue to be of importance with regards to the testing of many medical countermeasures, including vaccine and anti-viral medication, 58 technology will continue to advance and the importance and role of DSI in the context of global public health will grow alongside it. With researchers able to freely access and share DSI via online gene-banks, such as GenBank and GISAID, it is only a matter of time and increased technical capabilities 59 before DSI can be used in place of physical organisms in research and development, 60 reducing the need to negotiate access to physical pathogen samples in the process. Already, we are seeing the development of novel approaches to vaccine development which do not require access to physical pathogen samples but instead utilize DSI, with these approaches being expected to not only result in the development of better vaccine, but also to significantly decrease the time required to manufacture them. 61 The growing role of DSI in global public health has been evidenced by the COVID-19 pandemic, where the decision of researchers to share the SARS-CoV-2 genome sequences with the rest of the world via GISAID and GenBank enabled vital research and the development medical countermeasures to begin before physical pathogen samples could be isolated and accessed. 62 54 As has been noted above, dematerialisation here refers to the act(s) of separating information from physical pathogen samples. This act(s) reduces the need of pharmaceutical companies and research institutes to access physical samples. 55 In discussions surrounding the PIP Framework, this information is referred to as Genetic Sequence Data (GSD). Whilst it is important to recognise the differences in the terminology utilised during discussion surrounding DSI or GSD across difference regimes, this paper will treat the two as interchangeable terms and will favour the use of 'DSI' throughout. 56 DSI in these discussions refers to 'both indicative and contextual information including nucleic acid sequence reads and the associated data, information about the sequence assembly, annotation and maps describing whole genomes, individual genes or fragments, barcodes, organelle genomes and single nucleotide polymorphisms, information about gene expression, data on macromolecules and cellular metabolites, information on ecological relationships and abiotic factors of the environment, and so on.

III.A. DSI as a Threat to Global Health Justice
As the importance of DSI during the beginning of the COVID-19 pandemic has highlighted, enhanced technological capabilities with regards to the dematerialization, and potential subsequent re-materialization, of pathogen samples have the potential to provide great benefits to global public health, whether that be in the form of enhanced access to vital information or improvements in the accuracy of diagnostic tools, for example. With such capabilities being expected to develop further, it is anticipated that the dematerialization and subsequent re-materialization of pathogen samples will 'only increase in efficiency and ease, and decrease in entry costs, leading to a proliferation of its availability', 63 reducing the need for access to physical pathogen samples. The array of potential benefits arising from advances in synthetic biology are coupled with numerous risks and the potential to cause the serious loss of wellbeing and life on a global scale. Whilst the risks associated with synthetic biology are typically framed in relation to threats posed to global health security, due to an enhanced risk of bioterrorism and synthetically derived pandemics, much less consideration has been afforded to the threat synthetic biology, specifically the dematerialization of virus samples, poses to global health justice with regards to the distribution benefits, such as vaccine and other medical countermeasures.
As has already been acknowledged, the preferred solution to the difficulties faced by developing states in accessing medical countermeasures during a health emergency is the use of transactional ABS agreements which are provided for by the CBD, the Nagoya Protocol, and the PIP Framework. With DSI now beginning to assume a similar role to that of physical pathogen samples, if DSI is capable of being shared freely without the imposition of benefit-sharing obligations linked to its utilization, the attempts made by the CBD, the Nagoya Protocol, and the PIP Framework to place fair and equitable benefit-sharing on equal footing with pathogen sharing will be undermined. As such, any international ABS framework, and the manner in which that framework is incorporated into national ABS legislation, will need to reflect the view that 'Benefit-sharing arrangements for commercial and non-commercial use of DSI should reflect the same or similar benefit-sharing obligations as those attached to biological materials'. 64 The failure to incorporate DSI within the ABS transaction would ultimately reduce the ability of developing states to access medical countermeasures during a pandemic and could have detrimental implications for existing ABS arrangements, 65 posing a threat to global health equity and justice in the process.

III.B. The Benefit-Sharing Loophole
The growing use of DSI is the latest cause for dispute with regards to the negotiation of ABS agreements, most notably in relation to benefit-sharing obligations. 66 As increased use of DSI gradually negates the need to access physical pathogen samples, questions 63  have been raised with regards to what this means for ABS governance-are the CBD, the Nagoya Protocol, and the PIP Framework flexible enough to encompass these changes or is it the equivalent of 'regulat(ing) VCR technology in the era of You-Tube'? 67 Are these rapid changes in the field of synthetic biology significant enough to completely de-stabilize ABS, specifically the benefit-sharing obligations upon which developing states have become reliant in order to gain access to medical countermeasures and other benefits? 68 With genetic resources having long been understood by their physical materiality, 69 the application of the CBD, the Nagoya Protocol, and the PIP Framework to DSI is heavily disputed and remains unclear. 70 The source of this uncertainty finds its origins in the scope of each legal instrument, with none of them containing explicit reference to DSI. The CBD-and subsequently the Nagoya Protocol-defines 'genetic resources' as 'genetic material of actual or potential value;' with 'any material of plant, animal, microbial or other origin containing functional units of heredity' being categorized as 'genetic material'. 71 The reference to 'material' here suggests that both the CBD and Nagoya Protocol apply only physical pathogen samples, excluding 'intangible aspects', such as DSI, from their scope of application in the process. 72 As DSI is broadly understood to fall beyond the scope of both instruments, 73 neither PIC nor MAT are required, meaning that DSI can successfully be accessed under the CBD and the Nagoya Protocol without the successful negotiation of an ABS agreement and the imposition of benefit-sharing obligations.
Similarly, the primary element of the PIP Framework's provisions on ABS-the SMTA2s-apply only to PIP Biological Materials (BM), excluding the associated DSI from their scope. 74 Unsurprisingly, given the limited application of the PIP Framework, PIP BM only includes, 'human clinical specimens, virus isolates of wild type human H5N1 and other influenza viruses with human pandemic potential; and modified viruses prepared from H5N1 and/or other influenza viruses with human pandemic potential developed by WHO GISRS laboratories" and "RNA extracted from wild-type H5N1 and other human influenza viruses with human pandemic potential and cDNA that encompass the entire coding region of one or more viral genes'. 75 The exclusion of DSI from this definition means that SMTA2s are only required for access to physical samples of PIP BM and not their associated DSI.
A clear distinction exists, therefore, between the physical pathogen samples, which form part of the ABS transaction and general obligations which encourage the free and 12 • Pathogen dematerialization and the ABS loophole timely 'disclosure and exchange of information about these resources'. 76 The problem which arises here is a direct result of DSI being able to bypass the ABS obligations of the CBD, the Nagoya Protocol, and the PIP Framework, with third-party users being able to access DSI without the negotiation of an ABS agreement. 77 This, in turn, functions to produce what is commonly referred to as a 'benefit-sharing loophole', where users are able to access and utilize DSI without being bound by the terms of access and benefitsharing obligations, which stem from the use of MTAs and SMTA2s within the ABS agreement. 78 The threat posed by the existence of a 'benefit-sharing loophole' here is somewhat negated in the context of the PIP Framework as 'all current major influenza vaccine manufacturers have signed SMTA2s with WHO', with these agreements remaining valid and enforceable regardless of whether manufacturers utilize physical pathogen samples or rely entirely on DSI in the development of vaccine in the future. 79 There remains a risk, however, that new and emerging manufacturers will one day be able to be wholly reliant upon the use of DSI, negating the need for access to physical pathogen samples at any stage in the development process and therefore no longer requiring the negotiation of an SMTA2.
With it becoming increasingly possible for vaccine and other medical countermeasures to be developed and manufactured through the use of DSI which is freely available, the incentive for entering into an ABS agreement is significantly diminished. 80 Concerns surrounding the ability of DSI to bypass ABS and the risk that researchers may opt to synthesize genetic resources rather than be subject to benefit-sharing obligations and access restrictions 81 are met with equally pressing concerns surrounding the detrimental impact that including DSI within the ABS transaction may have on 'information exchange and open science', both of which are vital for a timely response during a health emergency. 82 It is questionable as to whether ABS agreements, such as those provided for by the CBD, the Nagoya Protocol, and the PIP Framework, are capable of keeping up with scientific advances in relation to DSI or even if they are the most suitable means of regulating access to DSI and the sharing of benefits resulting from its use. 83 The problem and how it might be addressed is the subject of ongoing discussion. Whilst recommendations for DSI to be treated in the same way as physical virus samples under the PIP Framework were made during a review in 2016, 84 and although 76  DSI formed a significant part of discussions at the 2016 UN Biodiversity Conference (COP13), 85 a solution which ensures fairness, equity and justice has yet to be found.

IV. CLOSING THE BENEFIT-SHARING LOOPHOLE
The 'benefit-sharing loophole' which is produced due to the ability of DSI to bypass ABS obligations functions to seriously undermine 'global efforts to more equitably distribute the benefits of research and development' 86 and as such, must be closed. Whilst difficulties have arisen in relation to finding a solution at the policy-level, numerous solutions for how to close the 'benefit-sharing loophole' have been proposed at the academic level. The remainder of this paper will examine some of these proposals in detail in order to determine not just their viability, but their ability to deliver equity and justice in global health.

IV.A. The Role of National ABS
Whilst limited in nature to the ABS obligations under the CBD and the Nagoya Protocol, a partial solution to the 'benefit-sharing loophole' emerges through the acknowledgement that the parties to the Nagoya Protocol are able to include reference to dematerialized pathogen samples within their national ABS legislation, requiring a user to obtain PIC and to negotiate MAT which define conditions for the access and utilization of DSI, as well as the sharing of benefits arising from its use.
Under the Nagoya Protocol, each Party is obliged to take 'appropriate, effective and proportionate legislative, administrative or policy measures'-including the implementation of national ABS legislation 87 -'to provide that genetic resources utilized within its jurisdiction have been accessed in accordance with prior informed consent and that mutually agreed terms have been established'. 88 The flexibility afforded to the Parties of the Nagoya Protocol here has made it possible for 'genetic resources' to be expanded in accordance with the individual requirements of each Party, with it being possible to capture DSI and the benefits resulting from its use within the ABS transaction as a result. 89 This suggested avenue for closing the benefit-sharing loophole is not purely hypothetical in nature, with a growing number of countries having already taken steps to regulate DSI within their national ABS legislation or within the terms and conditions associated with access to physical samples. In 2015, for example, new ABS legislation was adopted in Brazil which governed the utilization of information surrounding the 'genetic origin of plant, animal or microbial species'. 90 The consequence here is the closing of the benefit-sharing loophole, albeit on a national level, which reduces the threat posed by the dematerialization of pathogen samples to equity, fairness, and global health justice.
However, the flexibility afforded to the Parties to the Nagoya Protocol in relation to the implementation of national ABS legislation will produce significant differences across states. As the WHO has acknowledged, this will function to produce a 'patchwork of different legislation and measures covering the sharing of DSI', which would produce greater problems as opposed to providing a true solution and closing the 'benefit-sharing loophole'. 91 This 'patchwork' of legislation is likely to impose ABS obligations which range from stifling to non-existent, with the result here being an increase in 'jurisdiction shopping' by those seeking to obtain access to DSI, with the intention of finding the least restrictive benefit-sharing obligations. 92 Rather than ensuring the fair and equitable distribution of benefits resulting from the use of DSI and thereby closing the 'benefit-sharing loophole', the reliance on national ABS legislation and the risk of 'jurisdiction shopping' here functions to further limit the distribution of benefits during a health emergency to those states with the least demanding obligations, if benefit-sharing occurs at all.

IV.B. Including DSI within the Scope of the CBD, the Nagoya Protocol and the PIP Framework
Perhaps the most obvious solution to the 'benefit-sharing loophole' and the threat pathogen dematerialization poses to global health justice would be to expand the definition of genetic resources under the CBD and the Nagoya Protocol, alongside the definition of PIP BM under the PIP Framework, to include DSI, thereby capturing it within the respective ABS transactions. Current lines of argument, however, suggest that it is not necessary to expand these definitions as both already use appropriate terms that are sufficient to include reference to DSI. 93 This is based on the understanding that the use of the 'material' within the definition of both genetic resources and PIP BM is broad enough to include reference to information. 94 Taking this approach to closing the 'benefit-sharing loophole' would seemingly introduce greater consistency, whilst ensuring that DSI is subject to benefit-sharing obligations. Contention exists, however, within the international community as to whether the definition of genetic resources or PIP BM could or should be recognized as including DSI. 95 According to Bagley, the main views that exist surrounding DSI and the scope of the CBD/Nagoya Protocol can be split into three, with the first being that 'DSI is not within the definition of "genetic resources" but may result from utilization of genetic resources and can be addressed in MAT. Beyond MAT, DSI itself is a global non-monetary benefit and no further benefit-sharing for its use need be provided'. 96  additional benefit-sharing obligations, 97 producing considerable tension between the Global North and the Global South as a result. During COP13, for example, whilst Canada and other members of the Global North were astute in their belief that 'the Nagoya Protocol is about the ABS of genetic material only', as opposed to genetic resources and DSI, many delegations from the Global South were keen to stress the fact that 'resources are precious due to information that they contain'. 98 The second view is that '"genetic resources" should be interpreted to include DSI such that DSI is subject to PIC/MAT under the Nagoya Protocol', although a combination of unrealistic expectations and impractical solutions with regards to how DSI could be governed under the current ABS regime have underscored a lack of support for this approach during discussions. 99 The final view for consideration here is that 'DSI is not within the definition of "genetic resources," but does result from their utilization. Monetary benefits should be shared from commercial uses' but that 'nonmonetary benefits, while important, are not sufficient to comply with Nagoya Protocol obligations'. 100 With this seemingly being the prevailing viewpoint, going so far as to somewhat bridge the gap between the Global North and Global South, it remains unlikely-but not impossible-that the definition of 'genetic resources' under the CBD/Nagoya Protocol with be interpreted to include DSI in the future.
Similar discussions have occurred within the context of the PIP Framework, although the leaving view here is that the definition of PIP BM should not be expanded to include DSI as it should not be 'subject to the liabilities associated with the legally binding SMTA2 requirements'. 101 The lack of consensus-alongside the apparent power imbalance, which exists here between the Global North and the Global South-suggest that neither the interpretation of the pre-existing definitions of 'genetic resources' and 'PIP BM' as including DSI, nor the expansion of those definitions, is probable, despite the existence of 'credible suggestions' that the current definitions are poorly suited to the problems which the use of ABS aims to overcome. 102 the growing role of DSI within global public health, a solution must be found which closes the 'benefit-sharing loophole' whilst ensuring that fairness, equity and justice are upheld.

V. CONCLUDING REMARKS: THE NEED FOR AN ALTERNATIVE SOLUTION
In order to ensure the realization of fairness, equity, and justice in global public health, DSI must ultimately not be allowed to bypass the ABS obligations contained within the CBD, the Nagoya Protocol, the PIP Framework, or any other ABS mechanisms which may emerge in the future. However, the current suggestions for how to capture DSI within the ABS transaction are insufficient, often producing greater problems in the long run.
As has been evidenced within this paper, the ABS transaction is a 'poor policy fit' 126 for ensuring both access to DSI and the fair and equitable sharing of the benefits resulting from its use. As such, it is it is vital that greater consideration is afforded to the question of whether there is an alternative means of achieving the aims of the ABS transaction-namely the equitable distribution of benefits arising from the utilization of genetic resources or access to PIP BM-in the context of access to DSI, without actually capturing DSI within the ABS transaction. 127 The way forward here may be to take a step away from the use of ABS, not just as a potential solution to the benefit-sharing loophole and the growing threat of pathogen dematerialization, but in the regulation of pathogen sharing overall. After all, there have long been questions surrounding the suitability of ABS to pathogens, 128 with this seemingly being the case regardless of whether they are in their physical form or dematerialized. The challenge, therefore, is to provide a more suitable mechanismor mechanisms-for resolving the two issues acknowledged within the Introduction: the pressing need for researchers and other actors within the field of pandemic preparedness to gain access to novel pathogen samples in a timely manner; and the limited availability of vaccine and other medical countermeasures during a health emergency, with developing states typically struggling to gain sufficient access to such resources in a timely manner due to developed states dominating procurement. 129 Now is the time to finally treat these issues for what they are-separate, distinct and unsuited to a single solution-whilst still recognizing that alternative solutions must be found simultaneously due to the perceived dependency of developing states on their ability to trade their sovereign genetic resources in order to access vaccine and other medical countermeasures during a health emergency. Whilst problems are likely to emerge in the search for alternative solutions, particularly with regards to the difficulties faced by developing states in procuring vaccine and other medical countermeasures during